510(k) · Cleared
Cleared4CIS Peek, Plif and Tlif Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solco Biomedical Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 6, 2010 after a 174-day review. The FDA summary names no predicate by number. 49 later devices descend from it.
- Decided
- Jan 6, 2010
- Review
- 174 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 6 citing it directly.
- This deviceK092162 4CIS Peek, Plif and Tlif Cage SystemSolco Biomedical Co., Ltd. · 2010
- Descendant · cites it directly · 38 of its ownK110783 Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd. · 2011
- Descendant · cites it directly · 37 of its ownK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 36 of its ownK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 29 of its ownK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · 3 generations on · 10 of its ownK181380 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd. · 2011 · cites it directly38descendants
- K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly37descendants
- K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly36descendants
- K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015 · 2 generations on29descendants
- K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092162 | 4CIS Peek, Plif and Tlif Cage System | Solco Biomedical Co., Ltd. | 2010 | — |
| +1 | K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | L&K BIOMED Co., Ltd. | 2011 | — |
| +1 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| +3 | K181380 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (49)
See all 496 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | 2011 | 38 |
| K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 37 |
| K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 36 |
| K120464 | Innesis Peek Cage | 2013 | 6 |
| K121567 | Oracle Lumbar Intervertebral Body Fusion Cage System | 2012 | 5 |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage… | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110783 (L&K BIOMED Co., Ltd., 2011) has gone furthest, with 38 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The 4CISO PEEK PLIF is intervertebral body fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 4CISO PEEK PLIF TM IBF device is intended to be used with autologous bone…
Read the full statement (129 words)
The 4CISO PEEK PLIF is intervertebral body fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 4CISO PEEK PLIF TM IBF device is intended to be used with autologous bone graft to facilitate fusion. The 4CIS® PEEK PLIF TM IBEF device is to be used in patients, who have had six months of non-operative treatment. The device is to be implanted via a direct posterior approach. The 4018® PEEK PLIF TM device may be implanted singly or in pairs in the lumbosacral spine with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092162: 4CIS Peek, Plif and Tlif Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092162
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026